In order to bring products to the market, it is mandatory for medical device manufacturers to have a Quality Management System (QMS) in place. We can assist you to achieve this end with the following services:

• Establishment and implementation of Quality Management Systems (QMS).
• Preparation for certification of Quality Management Systems (QMS) according to FDA QSR, EU Directives (AIMD, MDD, and IVD) and Regulations (MDR and IVDR), EN/ISO13485 and MDSAP,
• Liaison with Certification Bodies.
• Pre-certification audits prior to FDA audits, Notified Body Audits or other bodies.
• Periodic compliance First and Second party Audits including Mock Audits.
• Maintenance of Quality Management Systems (QMS) and acting as your Quality Assurance Manager.